PMDA drug package insert
メリスロン錠6mg
PMDA Prescription drug · エーザイ株式会社 · package insert Apr 1, 2025
Key facts
| Brand names | メリスロン錠6mg, メリスロン錠12mg |
|---|---|
| Nonproprietary names | ベタヒスチンメシル酸塩 |
| Companies | 製造販売元／エーザイ株式会社, 発売元／科研製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | めまい・平衡障害治療剤 |
| Therapeutic category codes | 871339 |
| YJ codes | 1339005F1296, 1339005F2128 |
| Approval numbers | 21300AMZ00492000, 15300AMZ00229000 |
| Package insert edition | 第4版 |
| Package insert date | Apr 1, 2025 |
| PMDA document key | 170033_1339005F1296_1 |
| PMDA company code | 170033 |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- None Safety communications
- No PMDA review report published
- No Risk management plan (RMP)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMDA approved drugs and package inserts (Japan)
Japan's PMDA publishes the package insert (添付文書) of every prescription drug, OTC drug and regenerative medical product, with brand and nonproprietary names, YJ codes and approval numbers. Names appear in Japanese as published.
Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, package insert database · Source date: